FDA recalls some Valsartan-containing drugs

On July 17 2018, the U.S. Food and Drug Administration alerted health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is a chemical used in rocket fuel and is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to have contaminated the drug’s production at Zhejiang Huahai, a Chinese supplier which ships the medicine worldwide.

The FDA originally approved Valsartan as a treatment for high blood pressure, or hypertension, in adults and children age six and up. It’s also approved for use in adults to treat heart failure and to reduce the risk of death in patients who recently had a heart attack. Valsartan is in a class of hypertension medications known as angiotensin II receptor agonists that reduce the constriction of blood vessels so that blood flows more freely. Valsartan is a stand-alone medication or valsartan HCTZ, which combines valsartan with the diuretic hydrochlorothiazide.

Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should consult with their doctor.  It is important to note that not all products containing valsartan are being recalled.

To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company.

Recalled Products

Experts believe the contamination might date back to 2012, when Zhejiang Huahai changed its manufacturing process.

In its press release, the FDA stated: “The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

** UPDATE 5/6/19 **

Another 19 lots of losartan tablets, these made by Vivimed Life Sciences and distributed by Heritage Pharmaceuticals, have been recalled for exceeding the FDA allowable amount of NMBA.

This covers Losartan Potassium Tablets USP in strengths of 25mg, 50mg and 100mg in 90-count or 1,000-count bottles with these lot Nos.:

CLO17006A, CLO17007A, CLO17008A, CLO17009A, CLO17010A, CLO17012A, CLO17013A, CLO17014A, CLO17015A, CLO17016A, CLO17017A, CLO17009B, CLO18001A, CLO18002A, CLO18020A, CLO18021A, CLO18022A, CLO18023A and CLO18002B.

Patients that took the recalled products might be at risk for increased chance of developing cancer. Cohen and Malad LLP  attorneys are currently investigating multiple claims from clients who took Valsartan and have been diagnosed with liver damage, tumors, or lung cancer.

If you are a loved one have taken Valstaran and been diagnosed with liver damage, tumors, or lung cancer, please contact the law firm of Cohen and Malad, LLP for a free consultation.